AcipHex: Package Insert and Label Information (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 62856-243-30
AcipHex
rabeprazole Sodium
delayed- release
tablets
20 mg
30 tabletsRx Only

PRINCIPAL DISPLAY PANEL
NDC 62856-243-30
Aciphex
rabeprazole Sodium
delayed- release
tablets
20 mg
30 tablets
Rx Only
(click image for full-size original)
ACIPHEX rabeprazole sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-243
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABEPRAZOLE SODIUM (RABEPRAZOLE) RABEPRAZOLE SODIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CROSPOVIDONE, UNSPECIFIED
DIACETYLATED MONOGLYCERIDES
ETHYLCELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYDROXYPROPYL CELLULOSE (90000 WAMW)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
MAGNESIUM STEARATE
MANNITOL
SODIUM HYDROXIDE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color YELLOW (yellow) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code ACIPHEX;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62856-243-41 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (62856-243-41)
2 NDC:62856-243-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:62856-243-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020973 08/19/1999
Labeler — Eisai Inc. (831600833)

Revised: 09/2019 Eisai Inc.

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